drugset / Trial / NCT04692051

A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer

NCT04692051 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

It is a trial to compare the efficacy and safety of Nab-paclitaxel plus Cisplatin vs Gemcitabine plus Cispatin as first line chemotherapy in advanced biliary tract cancer.

Timeline

Start
2019-09-01
Primary completion
2021-03-01
Completion
2021-09-01

Outcome

Met primary endpoint

paper p = 0.0034, hazard ratio [HR] = 0.5136, 95%CI: 0.3136-0.8411). PMID 40819029 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 125 mg/m2 Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous

Indications